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For those running medical device companies, competitive intelligence (CI) isn’t just an option, it’s a prerequisite for success. The medical device market is huge––worth over $156 billion in the U.S. alone––and new innovations are highly valuable. Top medical device companies are always innovating new, life-saving devices that have the potential to disrupt entire sub-sectors of the broader medical devices industry. 

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The medical devices industry encompasses everything from surgical dressings and latex gloves to pacemakers and artificial limbs. In the U.S., medical devices are regulated by the Center for Devices and Radiological Health (CDRH), a branch of the FDA. 

Medical devices are classified as Class I, II, or III, with each class representing a different risk level. Products in each class face very different regulatory processes, and CI plays a different role in each class. The classes are organized as follows:

  • Class I - low-risk devices like bandages or wheelchairs.
  • Class II - intermediate risk products like catheters or pregnancy tests.
  • Class III - high-risk, life-sustaining devices including pacemakers and ventilators.

The Process of Bringing New Medical Devices to Market

It’s not uncommon to group medical device companies together with pharmaceutical and biotechnology companies under the life science umbrella. While there are some similarities, the process of bringing a new medical device to market differs greatly from developing a new drug. Logically, it follows that the CI process is different for medical device makers.

One key distinction is the amount of time it takes to bring a new product to market. It takes an average of 12 years to bring a new drug to market, but the process for bringing a new medical device is much shorter, taking anywhere between 3 - 7 years depending on the class of the device.

Bringing a Class I device to market is relatively straightforward, as 95% of Class I devices are exempt from the regulatory process. Class I devices are relatively commoditized, and there doesn’t tend to be huge investments in CI in this space. For Class II and Class III devices, it’s a different story, and the regulatory approval process generates valuable competitive intelligence data.

CI for Class II Devices: Premarket Notification 510(k)

The majority of Class II devices require the submission of a Premarket Notification 510(k). The role of the 510(k) is to demonstrate that the device is substantially equivalent to one already in commercial distribution in the U.S.

A 510(k) is also required when the manufacturer wants to change the intended use of their device, or materially update the technology used in the device. For many medical device companies, the 510(k) is a primary source of competitive intelligence. 

Each month, the FDA releases the details of all devices that have been granted 510(k) clearance; typically a couple of hundred devices each month. It’s important that medical device manufacturers track these, as each 510(k) represents a potential goldmine of information. 

Details included in a 510(k) vary from the materials used to make the product to the bench tests the product has passed in order to receive an approval. Companies must also name predicate devices, or comparable devices that are already commercially available. If your own device is named as a predicate for another company’s new device, it’s a good bet you’re about to see new competition enter your market.

The information contained in a 510(k) is highly valuable, but it’s not particularly easy to synthesize into a comprehensive overview of the competitive environment. That’s why many CI practitioners in the medical device field make use of software platforms like Knowledge360Ⓡ, which effectively source and process data, freeing CI professionals to spend more time on analysis. 

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CI for Class III Devices: Premarket Approval (PMA)

All Class III devices, as well as some of the most innovative Class II devices, must go through the FDA’s premarket approval process, which determines whether the devices are safe for use. While only around 10% of medical devices fall into Class III, they’re often the most valuable, as they make use of sophisticated new technologies and medical innovations.

Class III devices require sufficient scientific evidence before the FDA will approve them, which means that manufacturers must conduct clinical trials to establish the efficacy of their device. Before conducting clinical trials, manufacturers must seek an Investigational Device Exemption (IDE) from the FDA, which approves the device for use in a clinical trial setting. Unlike other FDA approvals discussed here, IDE approvals are not released to the public record.

From a CI standpoint, it’s important to track both clinical trials and the granting of subsequent premarket approvals. CI practitioners can use sources like Cortellis to monitor their competitor’s clinical trials, and when it comes to tracking PMA’s, lists are published monthly on the FDA’s website. 

Similar to the 510(k) process, this data is not particularly well-structured, or easy to make sense of. To drive better outcomes, many CI practitioners use CI analysis platforms like Knowledge360 to assist with data sourcing, tagging, and analysis.

Other Applications of CI in the Medical Device Industry

Of course, the utility of CI in the medical device industry doesn’t stop at the end of the approval process for new devices. It’s important that companies continuously monitor their entire competitive landscape and use CI practices to inform and shape their strategy.

Medical device companies can and do use CI to track competitor activity, including activities like new investments, key hires, or other indicators of a change in strategy. By tracking key indicators, companies are able to spot warning signs early, infer insights about their competitor’s strategies, and generally, better position their own business for the long run.

Related: Life Sciences Insights: CI State of Play

Using Knowledge360 for CI in the Medical Device Industry

Studies have shown that most medical device companies only have two employees responsible for CI. Quite frankly, it’s impossible to expect those individuals to effectively track all competitive and market activity using manual tools alone.

A better approach incorporates technology with strategy to deliver high-value CI insights and information to the leadership of the organization. Knowledge360 is the world’s first Intelligence Hub. It’s a powerful all-in-one software platform that sources, categorizes, and presents competitive and marketing intelligence. 

To learn more about Knowledge360 for medical device companies, schedule a demo

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